Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:47 AM
Study NCT ID:
NCT07381959
Status:
RECRUITING
Last Update Posted:
2026-02-02
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Brain Injury in Children With Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Ethylenediaminetetraacetic acid (EDTA)- and sodium citrate collection tubes will be used to collect plasma samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker(s) of brain injury', 'timeFrame': 'From enrollment until the end of study follow-up (up to 3 years after start of primary behandling for primary brain tumor, such as operation for brain tumor)', 'description': 'Exploratory. "Brain injury" includes, e.g., changes visible on magnetic resonance imaging and neurocognitive follow-up assessments.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiotherapy', 'Cranial radiation therapy', 'Plasma biomarkers', 'Extracellular vesicles', 'Proteomics', 'Childhood brain tumor'], 'conditions': ['Brain Tumor', 'Childhood Cancer', 'Childhood Brain Tumor']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to identify biomarkers of treatment-induced brain injury in children treated for primary brain tumors. The main question it aims to answer is:\n\nCan investigators identify sensitive plasma biomarker(s) of treatment-induced brain injury in children with primary brain tumors?\n\nResearchers will compare results between different treatment modalities (surgery, chemotherapy, radiation versus radiation-naive) and a healthy age- and sex-matched control population, to identify treatment-specific biomarkers.\n\nParticipants will provide plasma samples at the following time points: before surgery, 1-2 weeks after surgery, as well as at 3-, 6-, 12-, 18-, 24-, and 36 months after surgery. Participants who receive radiation treatment will also provide plasma samples before and during treatment (approximately every 2 weeks). Where possible, plasma samples are also collected before the start of any new treatment (e.g., chemotherapy). Healthy controls will provide samples once.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Groups A and B will be selected from all children, 0-17 years of age, in Sweden with primary (newly diagnosed) brain tumors.\n\nGroup C will be selected from:\n\n* Healthy sibling controls to other study participants, OR\n* Siblings to other children admitted to Uppsala University Hospital, OR\n* Other healthy children for example those who attend Uppsala University Hospital for another reason (e.g., minor elective daycare surgery).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria, Group A (treated with radiation):\n\n* Age 0-17 years old, AND\n* Diagnosed with primary brain tumor through surgery, biopsy, or other diagnostic method (e.g., for germinoma) at Uppsala University Hospital or at another university hospital in Sweden, AND\n* Referred for radiotherapy at Skandion Clinic in Uppsala and/or at their local hospital (in some cases), with/without the addition of other cancer treatments.\n\nInclusion Criteria, Group B (treated without radiation/radiation naive):\n\n* Age 0-17 years old, AND\n* Diagnosed with primary brain tumor through surgery, biopsy, or other diagnostic method (e.g., for optic pathway glioma in neurofibromatosis type 1 and germinoma) at Uppsala University Hospital or at another university hospital in Sweden, AND\n* Not referred to radiotherapy and treated with/without the addition of other cancer treatments.\n\nInclusion Criteria, Group C (healthy control group):\n\n* Age 0-17 years old at time of recruitment\n\nExclusion Criteria, Groups A + B:\n\n* Diagnosed with a tumor only in the spinal cord (solitary spinal tumor).\n* Diagnosed with a tumor considered palliative already at diagnosis (e.g., diffuse intrinsic pontine glioma)\n\nExclusion Criteria, Group C:\n\n* Have diagnosis of chronic disease that requires continuous medication.\n\nExclusion Criteria, all groups:\n\n* Unable to provide informed consent due to language difficulties.'}, 'identificationModule': {'nctId': 'NCT07381959', 'acronym': 'BiomarkCBT', 'briefTitle': 'Biomarkers of Brain Injury in Children With Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Biomarkörer för hjärnskada Hos Barn Med hjärntumör', 'orgStudyIdInfo': {'id': 'LUL-964455'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A - Radiation', 'description': 'Children diagnosed with primary brain tumors who are treated with surgery and radiation therapy, and/or other cancer treatment (n=160).'}, {'label': 'Group B - Radiation-naive', 'description': 'Children diagnosed with primary brain tumors who are treated with surgery and/or other cancer treatment, but not radiation therapy (n=200).'}, {'label': 'Group C - Healthy Controls', 'description': 'Healthy children without brain tumors (n=200).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christoffer Ehrstedt, MD, PhD', 'role': 'CONTACT', 'email': 'christoffer.ehrstedt@uu.se'}], 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Christoffer Ehrstedt, MD, PhD', 'role': 'CONTACT', 'email': 'christoffer.ehrstedt@uu.se', 'phone': '0046-(0)18-611-0114'}], 'overallOfficials': [{'name': 'Arja Harila, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data can only be shared upon reasonable request, with appropriate approvals in place.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Blekinge', 'class': 'UNKNOWN'}, {'name': 'Region Dalarna', 'class': 'UNKNOWN'}, {'name': 'Region Gotland', 'class': 'UNKNOWN'}, {'name': 'Region Gävleborg', 'class': 'OTHER'}, {'name': 'Region of Uppsala', 'class': 'UNKNOWN'}, {'name': 'Region Halland', 'class': 'OTHER'}, {'name': 'Region Jämtland Härjedalen', 'class': 'OTHER'}, {'name': 'Region Jönköping County', 'class': 'OTHER_GOV'}, {'name': 'Region Kalmar län', 'class': 'UNKNOWN'}, {'name': 'Region Kronoberg', 'class': 'UNKNOWN'}, {'name': 'Region Norrbotten', 'class': 'OTHER'}, {'name': 'Region Skåne', 'class': 'UNKNOWN'}, {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, {'name': 'Sormland County Council, Sweden', 'class': 'OTHER'}, {'name': 'Region Värmland', 'class': 'UNKNOWN'}, {'name': 'Region Västerbotten', 'class': 'OTHER_GOV'}, {'name': 'Region Västernorrland', 'class': 'UNKNOWN'}, {'name': 'Region Västmanland', 'class': 'OTHER'}, {'name': 'Region Örebro län', 'class': 'UNKNOWN'}, {'name': 'Region Östergotland', 'class': 'UNKNOWN'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Västra Götalandsregionen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}